Developing Viability Index for Machine Perfused Livers

Not Applicable

Recruiting

• Conditions: Liver Cirrhoses

• Registration Number: NCT03694691
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-26
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or female 18-75 years of age.
• Candidate for a deceased-donor liver allograft.

Exclusion Criteria

• Seropositivity for HIV-1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Peak transaminase value post transplant	1 Year	The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury

Secondary Outcome Measures

Name	Time	Method
Liver Graft Failure	1 Year
Kidney Failure	1 Year
Acute Liver Rejection	1 Year
Incidence of major Infection	1 Year
Hepatitis C Recurrence (in Hepatitis C positive recipients)	1 Year
Biliary Complications	1 Year
Death	1 Year

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States